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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K945480
Device Name MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
Applicant
Harry A. Schlakman
301 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Harry A. Schlakman
301 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number876.5090
Classification Product Code
KOB  
Date Received11/08/1994
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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